Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of De Novo Coronary Artery Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 408
- 主要终点
- Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard
研究概览
简要总结
This is a prospective, single-center study. The primary purpose of this study is to evaluate the sensitivity and specificity of offline computational ultrasonic flow ratio (UFR) with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of 408 patients with coronary vessel diameter stenosis ≥30% and ≤80% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of coronary artery stenosis will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction
- •Age ≥18 years
- •Written informed consent
- •Intermediated coronary lesions (diameter stenosis of 30%-80% by visual estimation from coronary angiography)
排除标准
- •Ineligible for diagnostic IVUS or FFR examination
- •Prior coronary artery bypass grafting of the interrogated vessels
- •Myocardial infarction within 72 h of coronary angiography
- •Severe heart failure
- •Serum creatinine levels >150 umol/L, or glomerular filtration rates <45 ml/kg/1.73 m2
- •Allergy to the contrast agent or adenosine
- •Life expectancy < 2 years
- •IVUS pullback not covering the entire lesion
- •Severe myocardial bridge in the interrogated vessel
结局指标
主要结局
Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard
时间窗: Immediately after the procedure
Sensitivity is defined as the proportion of UFR ≤ 0.80 in patients with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR \> 0.80 in patients without hemodynamically-significant stenosis as measured by FFR (FFR \> 0.80).
次要结局
- The AUC of UFR for coronary stenosis with FFR as the gold standard(Immediately after the procedure)
- Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the vessel level, using FFR as the reference standard(Immediately after the procedure)
- Diagnostic accuracy of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard(Immediately after the procedure)